Lateral flow assay housing with integrated sample and buffer solution delivery and measurement

ABSTRACT

A lateral flow assay (LFA) device includes a capillary pad and a sample port that holds the sample fluid before a hole is made in a cavity surface of the sample port. The LFA device includes a breaker with a tip to make a hole in the cavity wall of the sample port causing the sample fluid held inside the compartment to be applied to the capillary pad after the start of a test.

CLAIM OF BENEFIT TO PRIOR APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 17/353,230, filed on Jun. 21, 2021, published as U.S. PatentPublication 2021/0394174. U.S. patent application Ser. No. 17/353,230claims the benefit of U.S. Provisional Patent Application Ser. No.63/041,973, filed on Jun. 21, 2020, U.S. Provisional Patent ApplicationSer. No. 63/067,300, filed on Aug. 18, 2020, and U.S. Provisional PatentApplication Ser. No. 63/083,988, filed on Sep. 27, 2020. The contents ofU.S. patent application Ser. No. 17/353,230, published as U.S. PatentPublication 2021/0394174, U.S. Provisional Patent Application63/041,973, U.S. Provisional Patent Application Ser. No. 63/067,300, andU.S. Provisional Patent Application Ser. No. 63/083,988 are herebyincorporated by reference.

BACKGROUND

A Lateral flow assay (LFA), also referred to as lateral flowimmunochromatographic assay or lateral flow dipstick immunoassay, is adevice that is used to detect the presence (or absence) of a targetanalyte in a sample fluid without the need for specialized equipment.The lateral flow assays are widely used for medical diagnostics forpoint of care testing, home testing, or laboratory use.

A lateral flow assay typically includes a series of capillary pads fortransporting fluid. A sandwich assay format may be used for detectinganalytes that have at least two binding sites to bind to antibodies. Asample pad is used to receive a quantity of fluid (referred to as thesample fluid) and transport the sample fluid to an adjacent conjugatepad. The conjugate pad contains a solubilized antibody labeled with adetector such as colloidal gold nanoparticles. The antibody is specificto a certain analyte which is the target of interest in the samplefluid. Some lateral flow assays may not have a sample pad. In theseassays, the sample may be directly applied to the conjugate pad. As thesample fluid flows through the conjugate pad, the analyte (if any) inthe sample fluid binds with the labeled antibody on the conjugate padand forms an immunocomplex.

The immunocomplex then flows from the conjugate pad into an adjacentmembrane (or membrane pad). The membrane has one or more test lines.Each test line may contain an immobilized unlabeled antibody. As theimmunocomplex moves over a test line, the immunocomplex binds with theimmobilized antibody on the test line, resulting in a colored test line.When the sample fluid does not include the target analyte, noimmunocomplex is formed on the conjugate pad and no immunocomplex bindswith the immobilized antibody on the test line. As a result, the testline does not change color.

A lateral flow assay may also include a control line on the membrane. Ina sandwich assay format, the control line may contain an immobilizedantibody that binds to the free antibodies labeled with the detectorresulting in a colored control line, which confirms that the test hasoperated correctly regardless of whether or not the target analyte hasbeen present in the sample.

A competitive assay format may be used for detecting analytes thatcannot simultaneously bind to two antibodies. The sample pad and theconjugate pad in a competitive assay format are similar to the samplepad and the conjugate pad in the sandwich assay format. In thecompetitive assay format, the test line contains immobilized analytemolecules.

If the sample liquid does not contain the analyte, the labeled antibodyflows from the conjugate pad into the test line and binds to the analyteat the test line, resulting in a colored test line that indicates thelack of the target analyte in the sample liquid. If, on the other hand,the target analyte is present in the sample liquid, the analyte binds tothe labeled antibodies on the conjugate pad and prevents the labeledantibody to bind to the analyte at the test line, resulting in the lackof color on the test line. In a competitive assay format, the controlline may contain an immobilized analyte that binds to the freeantibodies labeled with the detector resulting in a colored controlline, which confirms that the test has operated correctly regardless ofwhether or not the target analyte has been present in the sample.

BRIEF DESCRIPTION OF THE DRAWINGS

The various embodiments of the present lateral flow assay housing withintegrated sample and buffer solution delivery and measurement now willbe discussed in detail with an emphasis on highlighting the advantageousfeatures. These embodiments depict the novel and non-obvious lateralflow assay housing with integrated sample and buffer solution deliveryand measurement shown in the accompanying drawings, which are forillustrative purposes only. These drawings include the followingfigures, in which like numerals indicate like parts:

FIGS. 1A-1B illustrate top perspective views of an example lateral flowassay device with a cap and a sealer for applying a predeterminedquantity of a sample through the sample port, according to variousaspects of the present disclosure;

FIG. 2A illustrates a front elevation cross sectional view of thelateral assay device of FIGS. 1A-1B when the cap is open, according tovarious aspects of the present disclosure;

FIG. 2B illustrates a front elevation view of the lateral assay deviceof FIG. 2A when the cap is closed, according to various aspects of thepresent disclosure;

FIG. 3 is a top view of a cross sectional of the lateral flow assay ofFIGS. 1A-1B, illustrating the operation of the actuator, according tovarious aspects of the present disclosure;

FIG. 4 is a top perspective view of the lateral flow assay of FIG. 3 ,illustrating the operation of the actuator, according to various aspectsof the present disclosure;

FIG. 5 is a top perspective view of an example breaker of a lateral flowassay device, according to various aspects of the present disclosure;

FIG. 6 illustrates a top cross sectional view of an example lateralassay device with circuitry for generating one or more alert signals,according to various aspects of the present disclosure;

FIG. 7 illustrates a top cross sectional view of the lateral assaydevice of FIG. 6 after the spring actuates the switch, according tovarious aspects of the present disclosure;

FIG. 8 illustrates a bottom view of an example lateral assay device,which includes a disinfecting pad, according to various aspects of thepresent disclosure;

FIG. 9 illustrates a top perspective view of an example lateral flowassay device with a push-in actuator, according to various aspects ofthe present disclosure;

FIG. 10 illustrates a top view of an example push-in actuator of alateral flow assay device, according to various aspects of the presentdisclosure;

FIG. 11 illustrates a side perspective view of the push-in actuator ofFIG. 10 , according to various aspects of the present disclosure;

FIG. 12 illustrates a bottom cross sectional view of the lateral assaydevice of FIG. 9 , according to various aspects of the presentdisclosure;

FIGS. 13A-13B illustrate top perspective views of an example lateralflow assay device with a cap and a sealer for applying a predeterminedquantity of a sample through the sample port and an actuator with arotating handle, according to various aspects of the present disclosure;

FIG. 14A illustrates a front elevation cross sectional view of thelateral assay device of FIGS. 13A-13B when the cap is open, according tovarious aspects of the present disclosure;

FIG. 14B illustrates a front elevation cross sectional view of thelateral assay device of FIG. 14A when the cap is closed, according tovarious aspects of the present disclosure;

FIGS. 15A-15B illustrate a top cross sectional view of an examplebreaker of a lateral flow assay device that includes a rotating handle,according to various aspects of the present disclosure;

FIG. 16 illustrates a top perspective view of an example breaker of thelateral flow assay device of 15A-15B, according to various aspects ofthe present disclosure;

FIGS. 17A-17C show top perspective views of an example lateral flowassay device with a cap and a sealer for applying a predeterminedquantity of a sample through the sample port, according to variousaspects of the present disclosure;

FIG. 18 illustrates a front perspective cross sectional view of thelateral assay device of FIGS. 17A-17C showing the cap being closed,according to various aspects of the present disclosure;

FIG. 19 illustrates a front elevation view of the lateral assay deviceof FIG. 18 , according to various aspects of the present disclosure;

FIG. 20 is a front elevation view of the cross section of an examplesample port of a lateral flow assay device, according to various aspectsof the present disclosure;

FIG. 21 is a front elevation view of the cross section of the sampleport of FIG. 20 after the cap is closed, according to various aspects ofthe present disclosure;

FIG. 22 is a front elevation view of the cross section of the sampleport, the buffer solution port, the actuator, and the breaker of FIGS.18 and 19 , according to various aspects of the present disclosure;

FIG. 23 is a front elevation view of the cross section of the sampleport, the buffer solution port, the actuator, and the breaker of FIG. 22after the actuator is pushed down, according to various aspects of thepresent disclosure; and

FIG. 24 is a front perspective view of the breaker of a lateral flowassay device, according to various aspects of the present disclosure.

DETAILED DESCRIPTION

One aspect of the present embodiments includes the realization that, theprevious lateral flow assay devices do not have a mechanism to controlthe amount of sample that is applied to the sample port. In the past, inorder to apply a measured amount of sample fluid to a later flow assaydevice, laboratory tools such as pipettes were used. Disposable pipettesintended for use in home test kits are often difficult to use and leadto errors in obtaining the correct amount of sample which may result inerrors in the outcome of the test. Since the lateral flow assay devicesare optimized for a particular amount of sample, applying a differentamount of sample may result in sub-optimal results, incorrect results,lack of consistency, etc.

The present embodiments, as described in detail below, solve theabove-mentioned problem by providing a lateral flow assay device thatincludes an integrated mechanism for applying a predetermined quantityof sample fluid to the lateral flow assay device's capillary pads andprevents any excessive amounts of the sample fluid from being applied tothe capillary pads. The lateral flow assay devices of presentembodiments provide a single step method for applying a predeterminedamount of sample, which provides the technical advantage of removing thesources of error, providing ease of use, and providing consistentresults.

The lateral flow assay device, in some embodiments, may include a sampleport and a buffer solution port. In some embodiments, the lateral flowassay device may include a quantity of buffer solution in the buffersolution port. For example, the buffer solution may be placed in thebuffer port and the buffer port may be sealed at the manufacturing time.

The sample port and the buffer solution port may each include a passagethrough which the sample fluid or the buffer solution may be applied tothe capillary pads, respectively. The passage may be a cavity with asurface. The cavity surface may include one or more walls. At least aportion of the cavity surface, in some embodiments, may be concave. Atleast a portion of the cavity surface of the sample port (e.g., a wallor a portion of a wall of the cavity surface) and/or a portion of thecavity surface of the buffer solution port (e.g., a wall or a portion ofa wall of the cavity surface) may be made of a material that may bebroken by pressing the breaker against the breakable portion of thesurface. Both passages may be configured to hold the applied fluidinside prior to the start of the test and may prevent the sample and thebuffer solution to be applied to the capillary pads until a hole isopened in the cavity surface of each port. The buffer solution port, insome embodiments, may be filled with a predetermined volume of thebuffer solution during manufacturing and may be sealed at the top.

The lateral flow assay device, in some embodiments, may include amovable cap. Once the sample fluid is applied to the sample port, thecap may be closed. The cap, in some embodiments, may include a sealerthat may be pushed inside the sample port and may snugly fit inside thesample port such that a compartment with a predetermined volume may beformed between the sealer and the sample port. The sealer may beconfigured such that pushing the sealer into the sample port may keepthe sample inside the compartment and may push any extra amount ofsample that does not fit inside the compartment out of the sample port.

The lateral flow assay device, in some embodiments, may include anactuator that may be connected to a breaker. The breaker may beconfigured to receive a force to press the breaker against the cavitysurface of the sample port. In response to receiving the force, thebreaker may make a hole in the cavity surface of the sample port,causing the sample fluid held by the sample port to be applied to thecapillary pads.

The actuator, in some embodiments, may include a button. Depressing theactuator's button may cause the breaker to make a hole in the cavitysurface of the sample port to allow the sample fluid inside thecompartment to be applied to the capillary pads of the lateral flowassay device. Depressing the actuator button may also cause the breakerto make a hole in the cavity surface of the buffer solution port inorder to allow the buffer solution that is kept inside the buffersolution port to be applied to the capillary pads of the lateral flowassay device. The breaker, in some embodiments, may include tips forpunching the holes in the cavity surface of the sample port and/or thebuffer solution port.

In some embodiments, at least a portion of the cavity surface of thesample port (e.g., a wall or a portion of a wall of the cavity surface)may be configured to be thin and breakable and the hole may be made inthe breakable portion of the cavity surface. In some embodiments, thecavity surface of the sample port (e.g., a wall of the cavity surface)may include a breakable tab and the hole may be made in the cavitysurface of the sample port by breaking the tab. In some embodiments, atleast a portion of the cavity surface of the buffer solution port (e.g.,a wall or a portion of a wall of the cavity surface) may be configuredto be thin and breakable and the hole may be made in the breakableportion of the cavity surface. In some embodiments, the cavity surfaceof the buffer solution port (e.g., a wall of the cavity surface) mayinclude a breakable tab and the hole may be punched in the cavitysurface of the buffer solution port by breaking the tab.

The actuator, in some embodiments, may include a slider that may be usedto push the breaker's tips to make the holes in the cavity surface ofthe sample port and the buffer solution port. In other embodiments, theactuator may be a push-in button actuator that may be used to push thebreaker towards the sample port and/or the buffer solution port in orderfor the breaker's tips to punch the hole in the cavity surface of thesample port and/or the cavity surface of the buffer solution port.

In other embodiments, the actuator may include a rotating handle, a cam,and a shaft. When the rotating handle is rotated, the cam may rotatearound the shaft and may push the breaker towards the sample port inorder for the breaker's tips to make the hole in the cavity surface ofthe sample port and/or the cavity surface of the buffer solution port.

Yet, in other embodiments, the actuator may be a button (e.g., a pushbutton) that may be connected to the breaker. The breaker may includetwo tips at two sides of a shaft. The tips may rest on a guide surface.The breaker may be configured such that the portion of the breaker thatincludes the tips is elastic. As the actuator is pressed and the breakeris pushed against the guide, the tips may move away from the shaft andtowards the cavity surface of the sample port and/or the cavity surfaceof the buffer solution port. The tips may then make the hole in thecavity surface of the sample port and/or the cavity surface of thebuffer solution port.

The sealer, therefore, may ensure that only the amount of sample thathas filled the predetermined volume of the compartment is applied to thecapillary pads. The breaker may ensure that the holes are punched intothe sample port and the buffer solutions port after the sample fluid isapplied to the sample port. The breaker may further ensure that thesample and the buffer solutions are both applied to the capillary pads.The buffer solution delivered to the sample pad may have a predeterminedvolume that is filled in the buffer port and sealed during themanufacturing of the lateral flow assay cartridge. The predeterminedamount is dependent on the test being performed by the lateral flowassay and is fixed for each type of test.

The lateral flow assay device's housing may be configured such that thesample port is located at an edge of the housing such that a portion ofthe sample port's rim is close to a side wall of the housing. When thesample fluid required for the test is blood, a person may punch afingertip with a lancet and may simply and easily press the fingertipagainst the rim of the sample port to apply a quantity of blood to thesample port. The position of the rim on the side of the housing providesthe technical advantage of allowing the blood to be applied from thefingertip to the sample port without spilling the blood on the lateralflow assay's housing. The rim and the position of the sample port mayeliminate the need for using a pipette or other sampling devices to pickthe blood from the finger and place it in the sample port.

The remaining detailed description describes the present embodimentswith reference to the drawings. In the drawings, reference numbers labelelements of the present embodiments. These reference numbers arereproduced below in connection with the discussion of the correspondingdrawing features.

FIGS. 1A-1B illustrate top perspective views of an example lateral flowassay device with a cap and a sealer for applying a predeterminedquantity of a sample fluid through the sample port, according to variousaspects of the present disclosure. With reference to FIGS. 1A-1B, thelateral flow assay device 100 may include a housing 105, a test resultsviewing window 110, one or more test lines 120, a control line 130, acap 140, an actuator 142, a sample port 165, a buffer solution port 170,and a sealer 180.

FIG. 1A shows the lateral flow assay device 100 with the cap 140 opened.FIG. 1B shows the lateral flow assay device 100 with the cap 140 closed,covering the sample port 165. For example, FIG. 1B may show the lateralflow assay device after a quantity of sample is applied to the sampleport and the cap 140 is closed to start the test. The cap 140 may beconnected to a flap 143 that may be rotate around the slot 141 in orderto open or close the sample port 165.

When the sample fluid required for the test is blood, a person may puncha fingertip with a lancet and may simply and easily press the fingertipagainst the rim 167 of the sample port 165 to apply a quantity of bloodto the sample port 165. The lateral flow assay device's housing 105, insome embodiments, may be configured such that the sample port 165 islocated at an edge of the housing 105 such that a portion of the sampleport's rim 167 is close to a side wall of the housing 105. In thepictured orientation, the sample port is located on the top, close to awall of the housing 105 that is not shown in the perspective view ofFIG. 1A. This wall 670 is shown, for example, in FIGS. 6, 9, and13A-13B, described below. The position of the rim 167 on the side of thehousing 105 provides the technical advantage of allowing the blood to beapplied from the fingertip to the sample port 165 without spilling theblood on the lateral flow assay's housing 105.

The rim 167 and the position of the sample port 165 may eliminate theneed for using a pipette or other sampling devices to pick the bloodfrom the finger and place it in the sample port 165. Disposable pipettesintended for use in home test kits are often difficult to use and leadto errors in obtaining the correct amount of sample which can result inerrors in the outcome of the test.

With further reference to FIG. 1A, the passage 168 may be a tube (whichmay be, e.g., and without limitations, at least partially funnelshaped). The buffer solution port 170 may include a passage 178. Thepassage 178 may be a tube (which may be, e.g., and without limitations,at least partially funnel shaped).

As described below, the passage 168 may be configured to hold the samplefluid until a hole is punched in the cavity surface of the sample port165 in order for the sample fluid to be applied to the lateral flowassay device's capillary pads. The buffer solution passage 178 may beconfigured to hold the buffer solution until a hole is punched in thecavity surface of the passage 178 in order for the buffer solution to beapplied to the lateral flow assay device's capillary pads.

In some embodiments, at least a portion of the cavity surface of thesample port (e.g., a portion of a wall) may be configured to be thin andbreakable and the hole may be made in the breakable portion of thecavity surface. In some embodiments, the cavity surface of the sampleport may include a breakable tab (e.g., on a wall of the cavity surface)and the hole may be made in the cavity surface of the sample port bybreaking the tab. In some embodiments, at least a portion of the cavitysurface of the buffer solution port (e.g., a portion of a wall) may beconfigured to be thin and breakable and the hole may be made in thebreakable portion of the cavity surface. In some embodiments, the cavitysurface of the buffer solution port may include a breakable tab (e.g.,on a wall of the cavity surface) and the hole may be made in the cavitysurface of the buffer solution port by breaking the tab. As describedbelow, the actuator 142 may be connected to a breaker with tips that maymake a hole and/or break a tab on the cavity surface of the ports 168and/or 178 when the actuator is activated.

In some embodiments, the lateral flow assay device may include aquantity of buffer solution in the buffer solution port 170. Forexample, the buffer solution may be placed in the buffer solution port170 and the buffer solution port 170 may be sealed at the manufacturingtime. In other embodiments, the buffer solution may be applied to thebuffer solution port 170 before the start of the test around the sametime as a sample fluid is applied to the sample port 165.

Yet other embodiments may perform a test that may not need a buffersolution. These embodiments may not include the buffer solution port ormay include the buffer solution port but not use the buffer solutionport for the test.

The sealer 180 on the cap 140 may be configured to snugly fit inside thesample port 165 such that a predetermined amount of sample fluid may betrapped inside the sample port's passage 168 and any additional amountof sample fluid may be blocked by the sealer 180 from reaching thelateral flow device's capillary pads.

The lateral flow assay device 100, in some embodiments, may include abar code 190 and/or a near field communication (NFC) chip (not shown).The bar code 190, in some embodiments may be, for example, and withoutlimitations, a one-dimensional (1D) barcode or a two-dimensional (2D)barcode. The bar code 190 and/or the NFC chip may identify the type(e.g., and without limitations, the model) of the lateral flow assaydevice, the type of test(s) to be performed by the lateral flow assaydevice, other parameters and information related to the test, etc. Thebar code 190 and/or the NFC chip may also include a unique serial numberused for authentication.

As described below with reference to FIGS. 6 and 7 , the lateral flowassay device 100, in some embodiments, may include a timer that may beactivated at the start of the test. The timer may turn an indicatorlight (e.g., and without limitations, a light emitting diode (LED)) 185on or off to indicate the start and/or the end of the test. The lateralflow assay device's housing 105 may include one or more holes 108 thatmay facilitate the passage of an alert sound that may indicate the endof the test after the expiration of the timer.

FIG. 2A illustrates a front elevation cross sectional view of thelateral assay device of FIGS. 1A-1B when the cap is open, according tovarious aspects of the present disclosure. FIG. 2B illustrates a frontelevation view of the lateral assay device of FIG. 2A when the cap isclosed, according to various aspects of the present disclosure.

With reference to FIGS. 2A-2B, when the cap 140 is closed, the sealer180 may snuggly fit inside the sample port 165 such that a compartment280 with a predetermined volume is formed inside the sample port betweenthe sealer 180 and the cavity surface of the sample port 165. Dependingon the type of the test performed by the lateral flow assay device 100,the shape and the size of the sample port 165, the shape of the cap 140,and the shape and the size of the sealer 180 are configured such thatthe compartment 280 may have a predetermined volume that may be requiredfor the test, and may hold an amount of sample fluid that does notexceed the predetermined volume.

Any amount of the sample fluid that does not fit inside the compartment280 may be pushed out of the sample port by the sealer 180. For example,in some embodiments, the extra sample fluid may be pushed over thesample port's rim 167 and may be kept under the cap 140. In someembodiments, the lateral flow assay device's housing 105 may include agroove (not shown) around the sample port 165 to hold the additionalsample fluid that may be pushed out of the sample port by the sealer180. The rim 167 may create an edge around the sample port 165 that israised over the surface of the housing 105 and may prevent theadditional sample fluid that is pushed out of the sample port 165 toreturn into the sample port's passage 168. Once the sample fluid isapplied to the sample port 165 and the cap 140 is closed, the sampleport's passage 168 may hold the sample until the actuator 142 isactivated, as described below with reference to FIG. 3 .

FIG. 3 is a top view of the cross section of the lateral flow assay ofFIGS. 1A-1B, illustrating the operation of the actuator 142, accordingto various aspects of the present disclosure. With reference to FIG. 3 ,the actuator 142 may include a plate 342 and a slider 330. The breaker345 may include the tips 321 and 322. One side of the actuator's plate342 may include a ramp 370 configured to push the breaker 345 towardsthe sample port 165 and the buffer solution port 170 in order for thetips 321 and 322 of the breaker 345 to make holes on the cavity surfacesof the sample port 165 and the buffer solution port 170, respectively.In some embodiments, at least a portion of a cavity surface of thesample port and/or a portion of the cavity surface of the buffersolution port may be made from a material that may break when the tips321 and 322 apply pressure to the breakable portion of the cavitysurface. In other embodiments, the cavity surface of the sample portand/or the buffer solution port may include breakable tabs that maybreak when the tips 321 and 322 apply pressure to the tabs in thecorresponding passages 168 and 178.

FIG. 3 , as shown, includes three operational stages 301-303. In stage301, the slider 330 that is connected to the actuator's plate 342 may beat position 311, which may be the left most position of the slider 330in the pictured orientation. The breaker 345, in stage 301, ispositioned on the ramp 370 such that the tips 321 and 322 may be closeto, or may be touching, the exterior of the cavity surface of the sampleport 165 and the exterior of the cavity surface of the buffer solutionport 170, respectively. The tips 321 and 322, in stage 301, may notapply any pressure to break the cavity surfaces of the sample port 165and the buffer solution port 170.

In stage 301, any sample fluid that is applied into the sample port 165may be kept in the passage 168 without getting in contact with thecapillary pad 365 of the lateral flow assay device 100. In theembodiments that include a sample pad, the capillary pad 365 may be thesample pad. In the embodiments that do not include a sample pad, thecapillary pad 365 may be the conjugate pad. In the embodiments thatinclude a plasma separator filter (red blood cell filter) the capillarypad 365 may be the filter pad.

In stage 302, the slider 330 may be moved in the direction of the arrow340 from the position 311 to the position 312. The ramp 370 may push thebreaker 345 towards the sample port 165 and the buffer solution port170. In some embodiments, the breaker 345 may be configured to move onthe direction of the arrow 347. For example, and without limitations,the lateral flow assay device 100, in some embodiments, may includestoppers and/or guides (not shown) around the breaker 345 to ensure thebreaker 345 may move in the direction of the arrow 347 when the breaker345 is pushed by the actuator's plate 342.

In stage 302, the tips 321 and 322 may apply pressure to the cavitysurface of the sample port 165 and the cavity surface of the buffersolution port 170, respectively. As shown, the tips 321 and 322 may havepunched a hole in the cavity surfaces of the sample port 165 and thebuffer solution port 170, respectively.

The slider 330, in stage 303, may be moved further in the direction ofthe arrow 340 from the position 312 to the position 313. The ramp 370may push the breaker 345 further towards the sample port 165 and thebuffer solution port 170. The tip 321, in stage 303, may have made ahole in the cavity surface of the sample port 165 that may be enough toallow the sample liquid in the sample port 165 to be applied to thecapillary pad 365. The tip 322, in stage 303, may have made a hole inthe cavity surface of the buffer solution port 170 that may be enough toallow the buffer solution liquid in the buffer solution port 170 to beapplied to the capillary pad 365.

It should be noted that, in some embodiments, the lateral flow assaydevice 100 may not include a buffer solution port. In these embodiments,the breaker 345 may not include the tip 322.

FIG. 4 is a top perspective view of the lateral flow assay of FIG. 3 ,illustrating the operation of the actuator 142, according to variousaspects of the present disclosure. FIG. 4 , as shown, includes threeoperational stages 401-403, which correspond to the operational stages301-303 of FIG. 3 , respectively.

The cap 140, the flap 143, and the sealer 180 of FIG. 1A are not shownin FIG. 4 to provide a better view of the sample port 165 and the buffersolution port 170. In stage 401, the slider 330 may be at the position311. The tips 321 and 322 are not visible in stage 401.

In stage 402, the slider 330 may have moved to the position 312. Asshown, the tips 321 and 322 have penetrated into the passages 168 and178, respectively. In stage 403, the slider 330 may have moved to theposition 313. As shown, the tips 321 and 322 have further penetratedinto the passages 168 and 178, respectively.

The tip 321, in stage 403, may have punched a hole in the cavity surfaceof the sample port 165 that may be enough to allow the sample liquid inthe sample port 165 to be applied to the capillary pad 365 (FIG. 3 ).The tip 322, in stage 403, may have punched a hole in the cavity surfaceof the buffer solution port 170 that may be enough to allow the buffersolution liquid in the buffer solution port 170 to be applied to thecapillary pad 365 (FIG. 3 ).

FIG. 5 is a top perspective view of an example breaker of a lateral flowassay device, according to various aspects of the present disclosure. Asshown, the breaker 345 may include the tips 321 and 322. Although thelateral assay device 100 described above included a buffer solution port170, some embodiments may not include a buffer solution port. In theseembodiments, the breaker 345 may only include the tip 321. In some ofthese embodiments, depending on the type of test and the type of thesample, a buffer solution may not be needed or the buffer solution maybe applied through the sample port prior to closing the cap 140 (FIG.1A).

The breaker 345 may include a ramp 510. The breaker's ramp 510 and theactuator's ramp 370 (FIG. 3 ) may be configured be touch each other whenthe actuator slider is moved, causing the breaker 345 to move towardsthe sample port 165 and the buffer solution port 170, as described abovewith reference to FIG. 3 .

The lateral flow assay device 100, in some embodiments may includeelectronic circuitry, such as, for example, and without limitations, atimer for generating one or more alert signals for indicating the startand/or the end of a test. FIG. 6 illustrates a top cross sectional viewof an example lateral assay device with circuitry for generating one ormore alert signals, according to various aspects of the presentdisclosure.

With reference to FIG. 6 , the lateral flow assay device 100 may includethe electronic circuitry 600. The electronic circuitry 600, for example,and without limitations, may be on a circuit board, a printed board, aset of separate electronic chips, etc. The electronic circuitry 600, insome embodiments, may include a timer 605, an audible alarm indicator615, a visual alarm indicator 620, a processor 625, one or morebatteries 630, a switch 650, one or more wireless transceivers (e.g.,and without limitations, to provide Bluetooth, Wi-Fi, etc.,connectivity) 680, and/or a location determination module, such as, forexample, and without limitations, a global positioning system (GPS)receiver 685. The electronic circuitry 600 may include additionalcomponents, such as, for example, and without limitations, capacitors,resistors, solenoids, buffers, etc.

With reference to FIG. 6 , the lateral flow assay device 100 may includea spring 660. The spring 660 may be in touch with the actuator's plate342 prior to the start of a test. For example, the lateral flow assaydevice 100, in some embodiments, may include a notch (not shown) thatmay hold the actuator's plate 342 in contact with the spring 660 priorto the start of the test. In these embodiments, the notch should beremoved prior to the start of a test in order to move the slider 330 andthe actuator's plate 342.

In some embodiments, the spring 660 may keep the switch 650 in anormally open state prior to the start of the test. The switch 650 maybe, for example, and without limitations, a miniature snap-actionswitch, or a microswitch, which is an electric switch that may beactuated by a small amount of physical force.

FIG. 7 illustrates a top cross sectional view of the lateral assaydevice of FIG. 6 after the spring 660 actuates the switch 650, accordingto various aspects of the present disclosure. With reference to FIG. 7 ,the slider 330, the actuator 142, and the actuator's plate 342 may havemoved in the direction of the arrow 340, away from the spring 660.

The spring 660 may be configured to close the switch when the actuator'splate 342 is in a position where the tips 321 and 322 have penetratedthe passages 168 and 178. In some embodiments, closing the switch 600may connect the battery (or batteries) 630 to other components of theelectronic circuitry. In some embodiments, closing the switch 600 maystart the timer 605. In other embodiments, after closing the switch 600,the processor 625 may start the timer 605.

The timer 605 may be pre-programmed, or may be programmed by theprocessor 625, to run for a time period that is required for thecompletion of the particular test for which the lateral flow assaydevice 100 is programmed. In some embodiments, once the timer 605expires, the timer 605 may generate one or more signals to activate theaudible alarm indicator 615 and/or the visual alarm indicator 620. Inother embodiments, once the timer 605 expires, the timer 605 may sendone or more signals to the processor 625. In response, the processor 625may activate the audible alarm indicator 615 and/or may activate thevisual alarm indicator 620. The lateral flow assay device's housing 105may include one or more holes 108 (FIG. 1A) that may facilitate thepassage of the visual alarm indicator's sound to the outside of thelateral flow assay device's housing 105. In some embodiments, a separatetimer module may not be needed, in which case the processor itself maycontrol the timing. In other embodiments, a processor may not be needed,in which case the timer chip itself may control the audio and visualalarms.

The audible alarm indicator 615 may be, for example, and withoutlimitations, an audio signaling device such as a beeper or a buzzer. Theaudible alarm indicator 615 may be mechanical, electromechanical, orpiezoelectric. The audible alarm indicator 615 may sound an audiblealarm, indicating the end of the test when the test results may be readyfor viewing.

The visual alarm indicator 620 may be, for example, and withoutlimitations, a light source such as an LED light. The visual alarmindicator 620 may visually indicate the end of the test. For example,the visual alarm indicator 620 turn on at the end of the test, may startblinking at the start of the test and may stay on without blinking atthe end of the test, etc.

The GPS receiver may receive the location of the lateral flow assaydevice from a group of satellite and may send the location to theprocessor. The processor may transmit the location of the lateral flowassay device to one or more authorized electronic devices through thewireless transceiver(s) and one or more networks. The location of thelateral flow assay device may be used by the authorized electronicdevice, for example, to collect statistics for geographical locationswhere a particular test is done by lateral flow assay devices.

It should be noted that part or all of the electronic circuitry 600, insome embodiments, may be optional. For example, some embodiments, maynot include any of the electronic circuitry 600. Some embodiments mayinclude all components of the electronic circuitry 600 (e.g., the timer605, the audible alarm indicator 615, the visual alarm indicator 620,the processor 625, the one or more batteries 630, the switch 650, theone or more wireless transceivers 680, and the GPS receiver 680). Yetother embodiments may not include some components of the electroniccircuitry 600 such as the GPS receiver 685, the wireless transceiver(s)680, the timer 605 and the audible alarm, and/or the visual alarmindicator 620 while including other components of the electroniccircuitry 600.

The lateral flow assay device, in some embodiments, may include adisinfecting pad for disinfecting the fingertip of a person who isproviding blood sample for the test. FIG. 8 illustrates a bottom view ofan example lateral assay device 100, which includes a disinfecting pad,according to various aspects of the present disclosure.

With reference to FIG. 8 , the lateral assay device 100 may include thedisinfecting pad 810. The disinfecting pad 810, in some embodiments, mayinclude an amount of disinfectant such as, for example, and withoutlimitations, an amount of rubbing alcohol. The disinfecting pad 810 maybe covered by a cover (not shown) that may keep the disinfecting pad 810wet and may be peeled off in order to disinfect the finger of a person.It should be understood that, in different embodiments, the size, theshape, and the location of the disinfecting pad 810 may be different.

The actuator in the embodiments described with reference to FIGS. 1A-7included a slider. In some embodiments, the actuator may include apush-in handle that may be used to push the breaker's tips to make ahole in the cavity surface of the sample port and/or the cavity surfaceof the buffer solution port. FIG. 9 illustrates a top perspective viewof an example lateral flow assay device with an actuator that includes apush-in handle, according to various aspects of the present disclosure.

With reference to FIG. 9 , the lateral flow assay device 900 may includea housing 105, one or more holes 108, a test results viewing window 110,one or more test lines 120, a control line 130, a cap 140, a slot 141, aflap 143, a sample port 165, a rim 167, a buffer solution port 170,passages 168 and 178, a sealer 180, an indicator light 185, a bar code190, an/or an NFC chip (not shown), which may be similar to thecorresponding components of FIGS. 1A-1B. The lateral flow assay device900 may include an actuator 942, which may include a push-in handle (orbutton) 943. The lateral flow assay device 900 may include capillarypads such as sample pad, conjugate pad, membrane, wicking pad, and/orfilter pad.

Similar to the lateral flow assay device 100 of FIGS. 6 and 7 , thelateral flow assay device 900 may include some or all of the electroniccircuitry 600, such as, a timer 605, an audible alarm indicator 615, avisual alarm indicator 620, a processor 625, one or more batteries 630,a switch 650, one or more wireless transceivers 680, and/or a GPSreceiver 685. The electronic circuitry may include additionalcomponents, such as, for example, and without limitations, capacitors,resistors, solenoids, buffers, etc. The lateral flow assay device 900may also include a spring 660, similar to the spring 660 of FIG. 6 .

The electronic circuitry may include additional components, such as, forexample, and without limitations, capacitors, resistors, solenoids,buffers, etc. The sample port 165 of the lateral flow assay device 900may be close to an edge of the lateral flow assay device 900, forexample close to the wall 670 to facilitate applying blood sample to thesample port 165.

FIG. 10 illustrates a top view of an example actuator with a push-inhandle of a lateral flow assay device, according to various aspects ofthe present disclosure. FIG. 11 illustrates a side perspective view ofthe actuator of FIG. 10 , according to various aspects of the presentdisclosure. With reference to FIGS. 10 and 11 , the actuator 942 mayinclude, and/or may be attached to, a breaker 1045. The breaker 1045 mayinclude the tips 1021 and 1022.

Although the lateral assay device 900 described above included a buffersolution port 170, some embodiments may not include a buffer solutionport. In these embodiments, the breaker 1045 may only include the tip1021. In some of these embodiments, depending on the type of test andthe type of the sample, a buffer solution may not be needed or thebuffer solution may be applied through the sample port prior to closingthe cap 140 (FIG. 9 ).

FIG. 12 illustrates a bottom cross sectional view of the lateral assaydevice of FIG. 9 , according to various aspects of the presentdisclosure. With reference to FIG. 12 , the actuator 942 may include thepush-in handle (or push-in button) 943. The actuator 942 may include,and/or may be connected to, the breaker 1045.

When the push-in handle 943 is pushed towards the sample port 165 (inthe direction of the arrow 1240), the tip 1021 may make a hole in thecavity surface of the sample port 165 that may be enough to allow thesample liquid in the sample port 165 to be applied to the capillary pad(not shown in the cross section of FIG. 12 ) located below the sampleport. When the push-in handle 943 is pushed in the direction of thearrow 1240, the tip 1022, may make a hole in the cavity surface of thebuffer solution port 170 that may be enough to allow the buffer solutionliquid in the buffer solution port 170 to be applied to the capillarypad (not shown) located below the buffer solution port 170.

In some embodiments, at least a portion of the cavity surface of thesample port (e.g., a portion of a wall of the cavity surface) and/or aportion of the cavity surface of the buffer solution port (e.g., aportion of a wall of the cavity surface) may be made from a materialthat may break when the tips 1021 and 1022 apply pressure to thebreakable portions of the walls. In other embodiments, the cavitysurface of the sample port (e.g., a wall of the cavity surface) and/orthe cavity surface of the buffer solution port (e.g., a wall of thecavity surface) may include breakable tabs that may break when the tips1021 and 1022 apply pressure to the corresponding tabs.

In embodiments described with reference to FIGS. 1A-7 , the actuatorincluded a slider and, in the embodiments described with reference toFIGS. 9-12 , the actuator included a push-in handle (or button). Theactuator, in some embodiments, may include a handle that may make acircular motion and may be connected to a cam that moves the breakerforward to make the breaker's tips make holes in the cavity surfaces ofthe sample port and the buffer solution port.

FIGS. 13A-13B illustrate top perspective views of an example lateralflow assay device with a cap and a sealer for applying a predeterminedquantity of a sample through the sample port and an actuator with arotating handle, according to various aspects of the present disclosure.With reference to FIGS. 13A-13B, the lateral flow assay device 1300 mayinclude a housing 105, one or more holes 108, a test results viewingwindow 110, one or more test lines 120, a control line 130, a cap 140, aflap 143, a sample port 165, a rim 167, a buffer solution port 170,passages 168 and 178, a sealer 180, an indicator light 185, a bar code190, an/or an NFC chip (not shown), which may be similar to thecorresponding components of FIGS. 1A-1B and 9 .

The lateral flow assay device 1300 may include an actuator 1342, whichmay include a rotating handle 1343. The lateral flow assay device 1300may include capillary pads such as sample pad, conjugate pad, membrane,wicking pad, and/or filter pad. In FIGS. 13A-13B, the rotating handle1343 of the actuator 1342 is at rest against the lateral flow assaydevice's housing 105. For example, the rotating handle 1343 may be atrest in a groove 1360 in the lateral flow assay device's housing 105.

FIG. 13A shows the lateral flow assay device 1300 with the cap 140opened. FIG. 13B shows the lateral flow assay device 1300 with the cap140 closed, covering the sample port 165. For example, FIG. 13B may showthe lateral flow assay device after a quantity of sample is applied tothe sample port and the cap 140 is closed to start the test. The cap 140may be connected to a flap 143 that may rotate in order to open or closethe sample port 165.

As shown in FIG. 13A, the edge 1311 of the flap 143 extends beyond thesealer 180. When the sealer 180 is pushed into the passage 168 andsnapped in, the extension of the edge 1311 of the flap 143 keeps theextra sample volume that is pushed out of the passage 168 from splashingout over the body of the cartridge and keeps the extra sample volumeconfined to the area near and under the top of the flap 143.

FIG. 14A illustrates a front elevation cross sectional view of thelateral assay device of FIGS. 13A-13B when the cap is open, according tovarious aspects of the present disclosure. FIG. 14B illustrates a frontelevation cross sectional view of the lateral assay device of FIG. 14Awhen the cap is closed, according to various aspects of the presentdisclosure.

With reference to FIGS. 14A-14B, when the cap 140 is closed, the sealer180 may snuggly fit inside the passage of the sample port 165 such thata compartment 280 with a predetermined volume is formed between thesealer 180 and the sample port 165. Depending on the type of the testperformed by the lateral flow assay device 100, the shape and the sizeof the sample port 165, the shape of the cap 140, and the shape and thesize of the sealer 180 are configured such that the compartment 280 mayhave a predetermined volume that may be required for the test, and mayhold an amount of sample fluid that does not exceed the predeterminedvolume.

Any amount of the sample fluid that does not fit inside the compartment280 may be pushed out of the sample port by the sealer 180. For example,in some embodiments, the extra sample fluid may be pushed over thesample port's rim 167 and may be kept under the cap 140. In someembodiments, the lateral flow assay device's housing 105 may include agroove (not shown) around the sample port 165 to hold the additionalsample fluid that may be pushed out of the sample port by the sealer180. The rim 167 may create an edge around the sample port 165 that israised over the surface of the housing 105 and may prevent theadditional sample fluid that is pushed out of the sample port 165 toreturn into the sample port's passage 168. Once the sample fluid isapplied to the sample port 165 and the cap 140 is closed, the sampleport's passage 168 may hold the sample until the actuator 1342 isactivated, as described below with reference to FIGS. 15A-15B.

FIGS. 15A-15B illustrate a top cross sectional view of an examplebreaker of a lateral flow assay device that includes a rotating handle,according to various aspects of the present disclosure. With referenceto FIGS. 15A-15B, the actuator 1342 may include the rotating handle1343, a cam 1510, and a shaft 1515. The actuator 1342 may include,and/or may be attached to, a breaker 1545. FIG. 16 illustrates a topperspective view of an example breaker of the lateral flow assay deviceof 15A-15B, according to various aspects of the present disclosure. Withreference to FIG. 16 , the breaker 1545 may include the tips 1521-1522and the groove 1530.

The cam 1510 may be configured to rotate with the rotating handle 1343such that when the rotating handle 1343 is rotated for a certain angularvalue, the cam 1510 may also rotate for the same angular value. In someembodiments, the cam 1510 and the shaft 1515 may be fixedly attached tothe rotating handle 1343. In other embodiments, the cam 1510 may befixedly attached to the shaft 1515, and the shaft 1515 may be fixedlyattached to the rotating handle 1343. Yet, some embodiments may notinclude the shaft 1515. In these embodiments, the cam 1510 may befixedly attached to the rotating handle 1343.

FIGS. 15A-15B, as shown, include three operational stages 1501-1503. Instage 1501, the rotating handle 1343 may be at rest close to, oragainst, the lateral flow assay device's housing 105. For example, inthe depicted embodiments, the rotating handle 1343 may be at rest in thegroove 1360 in the lateral flow assay's housing 105.

The cam 1510 may be positioned inside the breaker's groove 1530 and maybe configured to convert the rotary motion of the rotating handle 1343into a linear motion of the breaker 1545. For example, the cam 1510 maybe configured such that when the rotating handle 1343 is at rest closeto, or against, the lateral flow assay's housing 105 (as shown in stage1501), the breaker's tips 1521-1522 may be close to, or may be touching,the exterior of the cavity surface of the sample port 165 and theexterior of the cavity surface of the buffer solution port 170,respectively. The tips 1521 and 1522, in stage 1501, may not apply anypressure to break the cavity surfaces of the sample port 165 and thebuffer solution port 170.

In stage 1501, any sample fluid that is applied into the sample port 165may be kept in the passage 168 (FIGS. 13A-13B) without getting incontact with the capillary pad 365 of the lateral flow assay device1300. In the embodiments that include a sample pad, the capillary pad365 may be the sample pad. In the embodiments that do not include asample pad, the capillary pad 365 may be the conjugate pad. In theembodiments that include a plasma separator filter (red blood cellfilter) the capillary pad 365 may be the filter pad.

In stage 1502, the rotating handle 1343 may be rotated away from thelateral flow assay's housing 105 in the direction of the arrow 1550. Thecam 1510 and the shaft 1515, which are fixedly attached to the rotatinghandle 1343, may rotate with the rotating handle 1343. The cam 1515 isconfigured such that, when the cam 1515 rotates in the direction of thearrow 1550 (e.g., when the handle 1343 is rotating away from the housing105), the cam 1510 may push (e.g., to linearly move) the breaker 1545towards the sample port 165 and the solution port 170. The tips 1521 and1522 may apply pressure to the exterior of the cavity surfaces of thesample port 165 and the buffer solution port 170, respectively. As shownin stage 1502, the tips 1521 and 1522 may have made a hole in the cavitysurfaces of the sample port 165 and the buffer solution port 170,respectively.

In some embodiments, at least a portion of the cavity surface of thesample port (e.g., a portion of a wall of the cavity surface) and/or atleast a portion of the cavity surface of the buffer solution port (e.g.,a portion of a wall of the cavity surface) may be made from a materialthat may break when the tips 1521 and 1522 apply pressure to thecorresponding walls. In other embodiments, the cavity surface (e.g., awall of the cavity surface) of the sample port and/or the cavity surface(e.g., a wall of the cavity surface) of the buffer solution port's wallmay include breakable tabs that may break when the tips 1521 and 1522apply pressure to the corresponding tabs.

The rotating handle 1343, in stage 1503, may have rotated in thedirection of the arrow 1550 further away for its rest position. The cam1510 may be configured to further push the breaker 1545 towards thesample port 165 and the solution port 170. The tip 1521, in stage 1503,may have made a hole in the cavity surface of the sample port 165 thatmay be enough to allow the sample liquid in the sample port 165 to beapplied to the capillary pad 365. The tip 1522, in stage 1503, may havemade a hole in the cavity surface of the buffer solution port 170 thatmay be enough to allow the buffer solution liquid in the buffer solutionport 170 to be applied to the capillary pad 365.

Although the lateral assay device 1500 described above included a buffersolution port 170, some embodiments may not include a buffer solutionport. In these embodiments, the breaker 1545 may only include the tip1521. Depending on the type of test and the type of the sample, a buffersolution may not be needed or the buffer solution may be applied throughthe sample port prior to closing the cap 140 (FIGS. 13A-13B).

Similar to the lateral flow assay device 100 of FIGS. 6 and 7 , thelateral flow assay device 1300 may include some or all of the electroniccircuitry 600, such as, a timer 605, an audible alarm indicator 615, avisual alarm indicator 620, a processor 625, one or more batteries 630,a switch 650, one or more wireless transceivers 680, and/or a GPSreceiver 685. The electronic circuitry may include additionalcomponents, such as, for example, and without limitations, capacitors,resistors, solenoids, buffers, etc. The lateral flow assay device 1300may also include a spring 660, similar to the spring 660 of FIG. 6 . Thesample port 165 of the lateral flow assay device 1300 may be close to anedge of the lateral flow assay device 1300, for example close to thewall 670 to facilitate applying blood sample to the sample port 165.

The lateral flow assay device 1300, in some of the embodiments thatinclude some or all of the circuitry 600, may include a pin 1520 (FIGS.15A-15B). The pin 1520 may be configured to connect the battery (orbatteries) 630 to the rest of the electronic circuitry 600 componentsprior to start of a test. For example, the pin 1520 may sit against anormally open switch (e.g., similar to the switch 650 of FIGS. 6 and 7 )that keeps the battery (or batteries) 630 disconnected from the rest ofthe electronic circuitry 600 prior to start of a test (e.g., to save thebattery life). The switch may include a spring (e.g., similar to thespring 660 of FIGS. 6 and 7 ). Once the handle 1343 is rotated, the pin1520 is moved away from the spring of the switch and connects thebattery (or batteries) 630 to the other components of the electroniccircuitry 600.

In some embodiments, the actuator may include a push-in button and theportion of the breaker that includes the tips may be made of elasticmaterial. FIGS. 17A-17C show top perspective views of an example lateralflow assay device with a cap and a sealer for applying a predeterminedquantity of a sample fluid through the sample port, according to variousaspects of the present disclosure. With reference to FIG. 17A-17C, thelateral flow assay device 1700 may include a housing 105, a test resultsviewing window 110, one or more test lines 120, a control line 130, acap 1740, an actuator 1742, a sample port 165, a buffer solution port170, and a sealer 1780.

FIG. 17A shows the lateral flow assay device 1700 with the cap 1740closed, covering the sample and the buffer solution ports. For example,FIG. 17A may show the lateral flow assay device after a quantity ofsample is applied to the sample port and the cap 1740 is closed to startthe test.

FIG. 17B shows the cap 1740 is being opened or closed. As shown, the cap1740 may rotate around the hinges 1790. FIG. 17C shows the cap 1740being fully opened, for example, to apply sample fluid to the sampleport 165. FIG. 17C may also show the lateral flow assay device prior tothe start of a test and after applying the sample to the sample port.The sample port 165 may include a rim 167 and a passage 168.

When the sample fluid required for the test is blood, a person may puncha fingertip with a lancet and may simply and easily press the fingertipagainst the rim 167 of the sample port 165 to apply a quantity of bloodto the sample port's passage 178. This eliminates the need for using apipette or other sampling devices to pick the blood from the finger andplace it in the sample port. Disposable pipettes intended for use inhome test kits are often difficult to use and lead to errors inobtaining the correct amount of sample which can result in errors in theoutcome of the test. The passage 168 may be a tube (which may be, e.g.,and without limitations, at least partially funnel shaped). The buffersolution port 170 may include a passage 178. The passage 178 may be atube (which may be, e.g., and without limitations, at least partiallyfunnel shaped).

As described below, the passage 168 may be configured such that thepassage 168 may hold the sample fluid until a hole is punched in thecavity surface of the passage 168 in order for the sample fluid to beapplied to the lateral flow assay device's capillary pads. The passage178 may be configured such that the passage 178 may hold the buffersolution until a hole is punched in the cavity surface of the passage178 in order for the buffer solution to be applied to the lateral flowassay device's capillary pads.

The sealer 1780 on the cap 1740 may be configured to snugly fit insidethe passage of the sample port 165 such that a predetermined amount ofsample fluid may be trapped inside the sample port's passage 168 and anyadditional amount of sample fluid may be blocked by the sealer 180 fromreaching the lateral flow device's capillary pads.

FIG. 18 illustrates a front perspective cross sectional view of thelateral assay device of FIGS. 17A-17C when the cap is closed, accordingto various aspects of the present disclosure. FIG. 19 illustrates afront elevation view of the lateral assay device of FIG. 18 , accordingto various aspects of the present disclosure.

With reference to FIGS. 18-19 , when the cap 1740 is closed, the sealer1780 may snuggly fit inside the passage of the sample port 165 such thata compartment 1880 with a predetermined volume is formed between thesealer 1780 and the sample port 165. Depending on the type of the testperformed by the lateral flow assay device 1700, the shape and the sizeof the sample port 165, the shape of the cap 1740, and the shape and thesize of the sealer 1780 are configured such that the compartment 1880has a predetermined volume that may be required for the test, and mayhold an amount of sample fluid that does not exceed the predeterminedvolume.

FIG. 20 is a front elevation view of the cross section of an examplesample port of a lateral flow assay device, according to various aspectsof the present disclosure. With reference to FIG. 20 , the sample port165 may include a passage 168, a tab 2040, and a rim 167. The tab 2040may be breakable. Prior to the tab 2040 being broken, any sample fluidthat may be applied into the sample port 165 may be kept in the passage168 without getting in contact with the capillary pad 365 of the lateralflow assay device. In the embodiments that include a sample pad, thecapillary pad 365 may be the sample pad. In the embodiments that do notinclude a sample pad, the capillary pad 365 may be the conjugate pad. Inthe embodiments that include a plasma separator filter (red blood cellfilter) the capillary pad may be the filter pad.

FIG. 21 is a front elevation view of the cross section of the sampleport of FIG. 20 after the cap is closed, according to various aspects ofthe present disclosure. With reference to FIG. 21 , after the cap 1740is closed, the sealer 1780 may fit inside the passage 168 (FIG. 20 ) ofthe sample port 165. The sealer 1780, the sample port 165, and the cap1740 may form a compartment 1880. As described above, the sealer 1780,the sample port 165, and the cap 1740 may be configured such that thecompartment 1880 may hold a predetermined volume of sample fluid asrequired by the test performed by the lateral flow assay device.

Any amount of sample fluid that does not fit inside the compartment 1880may be pushed out of the sample port by the sealer 1780. For example,the extra sample fluid may be pushed over the sample port's rim 167 andmay be kept under the cap 1740. In some embodiments, the lateral flowassay device's housing 105 may include a groove (not shown) around thesample port 165 to hold the additional sample fluid that may be pushedout of the sample port by the sealer 1780. The rim 167 may create anedge around the sample port 165 that is raised over the surface of thehousing 105 and may prevent the additional sample fluid that is pushedout of the sample port 165 to return into the sample port's passage 168.Once the sample fluid is applied to the sample port 165 and the cap 1740is closed, the sample port's passage 168 may hold the sample until thetab 2040 is broken.

With reference to FIGS. 18 and 19 , the actuator 1742 may be a button(e.g., a push button) that may be connected to the breaker 1845. Thebreaker 1845 may include two tips 1821 and 1822. FIG. 22 is a frontelevation view of the cross section of the sample port, the buffersolution port, the actuator, and the breaker of FIGS. 18 and 19 ,according to various aspects of the present disclosure.

With reference to FIG. 22 , the buffer solution port 170 may include atab 2220. As long as the tab 2220 is not broken, the buffer solutionport 170 may hold the buffer solution inside the buffer solution port170 without allowing the buffer solution to reach the capillary pad 365.

With further reference to FIG. 22 , the breaker 1845 may include thetips 1820 and 1821. The tips may rest on the guide's 2260 surface. Thebreaker 1845 may be configured such that the portion of the breaker 1845that includes the tips 1820 and 1821 is elastic. As the actuator 1742 ispressed and the breaker 1845 is pushed down (e.g., is pushed towards thecapillary pad 365) against the guide 2260, the tips 1820 and 1821 maymove away from the shaft 2265 of the breaker 1845 and towards the cavitysurface 2261 of the sample port 165 and the cavity surface 2262 of thebuffer solution port 170, respectively.

FIG. 23 is a front elevation view of the cross section of the sampleport, the buffer solution port, the actuator, and the breaker of FIG. 22after the actuator is pushed down, according to various aspects of thepresent disclosure. As shown, when the breaker 1845 is pushed down bythe actuator 1745, the tips 1820 and 1821 are pushed away from the shaft2265 and towards the cavity surfaces, for example, the walls 2261 and2262, respectively. The tabs 2040 and 2220 may be configured to bebreakable. The tips 1820 and 1821 may apply force to, and break, thetabs 2040 and 2220, respectively.

Once the tab 2040 is broken, the opening 2351 may allow the sample fluidin the compartment 1880 to be applied, for example, by gravity as wellas the capillary action of the pad material, to the capillary pad 365.Once the tab 2220 is broken, the opening 2352 may allow the buffersolution in the buffer solution port 170 to be applied, for example, bygravity as well as the capillary action of the pad material, to thecapillary pad 365.

Although the embodiments of FIGS. 22 and 23 show a breakable tab 2040 inthe sample port and a breakable tab 2220 in the buffer solution portthat may be broken in order to apply the sample fluid and the buffersolution to the capillary pad 365, in other embodiments one or both ofthe tabs 2040 and 2220 may be replaced by thin, breakable walls. Inthese embodiments, at least a portion of the cavity surfaces (e.g., thewalls 2261 and 2262) may be configured to be thin and breakable.Pressing the tips 1820 and 1821 against the walls 2261 and 2262 maybreak the walls 2261 and 2262, respectively.

FIG. 24 is a front perspective view of the breaker of a lateral flowassay device, according to various aspects of the present disclosure. Asshown, the breaker 1845 may include the tips 1820 and 1821. At least theportion of the breaker 1845 that includes the tips 1820 and 1821 may beelastic such that pushing the tips 1820 and 1821 against a surface(e.g., the guide 2260 of FIGS. 22 and 23 ) may cause the tips 2220 and2221 to move away from the shaft 2265.

Although the lateral assay device 1700 described above included a buffersolution port 170, some embodiments may not include a buffer solutionport. In these embodiments, the breaker 1845 may only include the tip1820. Depending on the type of test and the type of sample, a buffersolution may not be needed or the buffer solution may be applied throughthe sample port prior to closing the cap 1740.

As described above, the lateral flow assay devices 100, 900, 1300, and1700 of the present embodiments provides ease of use, especially forhome test applications where the user may not have precision tools toapply a predetermined amount of sample to the sample port. The lateralflow assay device of the present embodiments, therefore, reduces thehuman errors by ensuring that the required amount of the sample fluidand the buffer solution are both applied to the capillary pads of thelateral flow assay device.

The lateral flow assay device of the present embodiments is configuredto deliver the same volume of sample (e.g., blood) and buffer solution(as required by a given test) every time that the same model (e.g., thesame configuration) of the lateral assay device is used, which makes theresults repeatable and more reliable.

The lateral flow assay device of the present embodiments eliminates theneed for external components, such as pipettes and buffer solutioncontainers/droppers in a lateral flow assay test kit package. Thelateral flow assay device of the present embodiments may include alancet integrated on the side of the lateral flow assay device's housingand an alcohol pad integrated on the back of the cartridge with aprotective cover that may get peeled back by the user.

The above description presents the best mode contemplated for carryingout the present embodiments, and of the manner and process of practicingthem, in such full, clear, concise, and exact terms as to enable anyperson skilled in the art to which they pertain to practice theseembodiments. The present embodiments are, however, susceptible tomodifications and alternate constructions from those discussed abovethat are fully equivalent. Consequently, the present invention is notlimited to the particular embodiments disclosed. On the contrary, thepresent invention covers all modifications and alternate constructionscoming within the spirit and scope of the present disclosure. Forexample, the steps in the processes described herein need not beperformed in the same order as they have been presented and may beperformed in any order(s). Further, steps that have been presented asbeing performed separately may in alternative embodiments be performedconcurrently. Likewise, steps that have been presented as beingperformed concurrently may in alternative embodiments be performedseparately.

1-19. (canceled)
 20. A lateral flow assay device, comprising: acapillary pad configured to: receive a blood sample; and move the bloodsample by capillary action; a test line for determining whether theblood sample comprises a target analyte; a housing encompassing thecapillary pad and the test line, a sample port configured to receive theblood sample; wherein the sample port comprises a rim raising above asurface of the housing, wherein the sample port is located at an edge ofthe housing such that a portion of the rim of the sample port is closeto a side wall of the housing; wherein the rim of the sample port isconfigured to apply a quantity of blood to the sample port when apunctured fingertip of a person is pressed against the rim of the sampleport.
 21. The lateral flow assay device of claim 20, wherein the sampleport is configured to hold the blood sample prior to a hole made in awall of the sample port, and wherein the sample port is configured toapply the blood sample to the capillary pad after the hole is made inthe sample port's wall, the lateral flow assay device furthercomprising: a cap comprising a sealer, the sealer configured to: fitinside the sample port after the sample port receives the blood sample;form a compartment for holding a predetermined volume of the bloodsample between said sample port's wall and the sealer; and push anyamount of the blood sample in excess of the predetermined volume out ofthe compartment after the cap is fitted inside the sample port.
 22. Thelateral flow assay device of claim 21, wherein the housing comprises agroove around the rim of the sample port, the groove configured to holdthe excess blood sample pushed out of the compartment by the sealer. 23.The lateral flow assay device of claim 20, wherein the sample portcomprises a cavity comprising a surface, wherein the sample portconfigured to: hold the blood sample prior to a hole made in the cavitysurface; and apply the blood sample to the capillary pad after the holeis made in the cavity surface.
 24. The lateral flow assay device ofclaim 23, wherein at least a portion of the cavity surface of the sampleport is made of a thin and breakable material, wherein the hole is madein the thin and breakable portion of the cavity surface.
 25. The lateralflow assay device of claim 23, wherein the cavity surface of the sampleport comprises a breakable tab, wherein the hole is made in the cavitysurface by breaking the tab.
 26. The lateral flow assay device of claim23 further comprising: a breaker comprising: a breaker comprising a tip,the breaker configured to: receive a force to press the tip against thecavity surface of the sample port; and in response to receiving theforce, make a hole in the cavity surface of the sample port with the tipcausing the blood sample held by the sample port to be applied to thecapillary pad.
 27. The lateral flow assay device of claim 26, whereinthe breaker comprises a groove, the lateral flow assay device furthercomprising: an actuator configured to apply the force to press the tipof the breaker against the cavity surface of the sample port, theactuator comprising: a rotating handle; and a cam positioned inside thebreaker's groove; wherein the cam is configured to: make a same angularrotation as the rotating handle, and convert the angular rotation of thecam into a linear motion of the breaker, wherein the rotating handle isconfigured to rotate from a first position to a second position, causingthe cam to push the breaker's tip to punch the hole in the cavitysurface of the sample port.
 28. The lateral flow assay device of claim27 further comprising: a housing comprising a groove; wherein therotating handle is configured to rest in the groove of the housing whenthe handle is in the first position.
 29. The lateral flow assay deviceof claim 27 further comprising: an actuator configured to apply theforce to press the tip of the breaker against the cavity surface of thesample port, the actuator comprising: a slider configured to move alonga substantially straight line from a first position to a secondposition; and a ramp configured to push the breaker's tip against thecavity surface of the sample port to punch the hole in the cavitysurface of the sample port as the slider is moved from the firstposition to the second position.
 30. The lateral flow assay device ofclaim 27 further comprising: an actuator configured to apply the forceto press the tip of the breaker against the cavity surface of the sampleport, the actuator comprising: a push-in handle attached to the breaker,wherein the push-in handle is configured to: receive a force; and inresponse to receiving the force, move the breaker, causing the breaker'stip to punch the hole in the cavity surface of the sample port.
 31. Thelateral flow assay device of claim 27 further comprising: an actuatorconfigured to apply the force to press the tip of the breaker againstthe cavity surface of the sample port, wherein the breaker comprises anelastic guide connected to the tip of the breaker, wherein the actuatoris configured to: receive a force; and apply the force to the breaker,wherein the breaker's elastic guide is configured to: receive the forcefrom the actuator; and in response to receiving the force, push the tipof the breaker to punch the hole on the cavity surface of the sampleport.
 32. The lateral flow assay device of claim 27, wherein the tip isa first tip, the lateral flow assay device further comprising: a buffersolution port comprising a cavity with a surface; the buffer solutionport configured to: receive a quantity of buffer solution; hold thebuffer solution prior to a hole made in the cavity surface of the buffersolution port; and apply the buffer solution to the capillary pad afterthe hole is made in the cavity surface of the buffer solution port;wherein the breaker comprises a second tip, wherein the breaker isconfigured to: press the second tip against the cavity surface of thebuffer solution in response to receiving the force; and in response toreceiving the force, make a hole in the cavity surface of the buffersolution port with the second tip causing buffer solution held insidethe buffer solution port to be applied to the capillary pad.
 33. Thelateral flow assay device of claim 32, wherein at least a portion of thecavity surface of the buffer solution port is made of a thin andbreakable material, wherein the second tip makes the hole in the thinand breakable portion of the cavity surface of buffer solution port. 34.The lateral flow assay device of claim 32, wherein the cavity surface ofthe buffer solution port comprises a breakable tab, wherein the secondtip makes the hole in the cavity surface of the buffer solution port bybreaking the tab.
 35. The lateral flow assay device of claim 20 furthercomprising: a housing; a disinfecting pad attached to the housing, thedisinfecting pad comprising: a quantity of disinfectant; and a peelablecover configured to keep the disinfecting pad wet.
 36. The lateral flowassay device of claim 20 further comprising: electronic circuitryconfigured to: set a timer to a duration of a test; start the timer at abeginning of the test; and generate an alert when the timer expires. 37.The lateral flow assay device of claim 36, wherein the electroniccircuitry comprises electronic circuitry to generate at least one of anaudible alert and a visual alert.
 38. The lateral flow assay device ofclaim 37 further comprising a housing encompassing the electroniccircuitry, wherein the housing comprises a plurality of holes tofacilitate a passage of the audible alert to an outside of the housing.39. The lateral flow assay device of claim 20 further comprising: aspring; and electronic circuitry comprising: a set of one or morebatteries configured to provide power to a rest of the electroniccircuitry of the lateral flow assay device; and an electronic switchconfigured to: connect the set of batteries to the rest of theelectronic circuitry of the lateral flow assay device when the switch isclosed; and disconnect the set of batteries from the rest of theelectronic circuitry of the lateral flow assay device when the switch isopen; wherein the spring is configured to: move with the breaker; keepthe electronic switch open prior to a beginning of a test; and close theelectronic switch when the tip of the breaker punches the hole in thecavity surface of the sample port.
 40. The lateral flow assay device ofclaim 20 further comprising: electronic circuitry comprising: aprocessor; a set of one or more wireless transceivers and a globalpositioning system (GPS) receiver, wherein the GPS receiver isconfigured to: receive a location of the lateral flow assay device froma plurality of satellites; and send the location to the processor,wherein the processor is configured to send the location of the lateralflow assay device to one or more electronic devices through the set ofone or more wireless transceivers and one or more networks.